Renal function analysis method and apparatus

Abstract

A method for measuring a glomerular filtration rate in a mammalian kidney comprises a source of reporter and marker fluorescent molecules. The fluorescent molecules are introduced into the blood stream of a mammalian subject. Over a period of time, a measurement of the intensities of the reporter and marker fluorescent molecules is taken. A ratio is calculated to determine the health of the subject's kidney. This method measures volume of plasma distribution based on a fluorescence of a marker molecule relative to a fluorescence of a reporter molecule.

1 - 28 . (canceled) 
     
     
         29 . An apparatus for analyzing the condition of a kidney, the apparatus comprising: a source of an analysis composition, the analysis composition comprising a plurality of fluorescent reporter molecules having a first fluorescence and a plurality of fluorescent marker molecules having a second fluorescence, where the reporter molecules have a molecular weight that is less than the molecular weight of the marker molecules;
 a percutaneously introducible catheter configured for introducing the analysis composition into a blood steam of a patient and for in situ delivery of excitation energy from an optical fiber extensible from a distal end of the catheter into the bloodstream of the patient and for collection of emission energy from within the bloodstream of the patient;   and a detector for monitoring a level of the analysis composition within the blood stream and reporting the operating condition of the kidney; wherein a volume of plasma distribution of the patient is calculated based on the fluorescence of the marker molecules, and wherein the fluorescence of the marker molecules relative to the fluorescence of the reporter molecules is calculated and reported as a measure of kidney function.   
     
     
         30 . The apparatus of  claim 29  wherein the reporter molecule is readily filtered by the kidney, and the marker molecule resists filtration by the kidney. 
     
     
         31 . The apparatus of  claim 30  wherein the first molecular weight is between about 3 kD and 70 kD. 
     
     
         32 . The apparatus of  claim 31  wherein the first molecular weight is between about 3 kD and 20 kD. 
     
     
         33 . The apparatus of  claim 29  wherein the reporter molecule and marker molecules are both dextrans. 
     
     
         34 . The apparatus of  claim 33  wherein the dextrans are conjugated with fluorescence. 
     
     
         35 . The apparatus of  claim 33  wherein the reporter molecule is fluorescein dextran. 
     
     
         36 . The apparatus of  claim 33  wherein the reporter molecule is a fluorescein isothiocyanate-inulin. 
     
     
         37 . The apparatus of  claim 33  wherein the marker molecule is a larger sulforhodamine 101 dextran that is not filtered by the kidney. 
     
     
         38 . The apparatus of  claim 29  wherein the fiber optic cable has a diameter of from about 0.5 mm to about 1.0 mm. 
     
     
         39 . The apparatus of  claim 29  wherein the detector is selected from the group consisting of photo multiplier tubes, photo detectors, solid state detectors, a charge-coupled device, and combinations thereof 
     
     
         40 . The apparatus of  claim 39  wherein the detector includes at least one LED source or laser diode, at least one optical filter, and at least one power supply. 
     
     
         41 . The apparatus of  claim 40  wherein the detector further comprises one of a dichroic and band pass filter. 
     
     
         42 . The apparatus of  claim 41  wherein the detector comprises a microcontroller. 
     
     
         43 . The apparatus of  claim 29  wherein the apparatus measures the glomerular filtration rate (GFR) of the kidney. 
     
     
         44 . An apparatus for analyzing the condition of a kidney, said apparatus comprising: a source of a kidney function analysis composition, the kidney analysis composition comprising a plurality of fluorescent reporter molecules having a first fluorescence and a plurality of fluorescent marker molecules having a second fluorescence, where the reporter molecules have a molecular weight that is less than the molecular weight of the marker molecules;
 a percutaneously introducible catheter comprising: a tubular main member defining a passageway between a proximal end and a distal end thereof, and an optical fiber extensible from the distal end; and   a detector, optically coupled to the optical fiber, for monitoring a level of the analysis composition within the blood stream and reporting vascular plasma volume and the operating condition of the kidney; wherein the volume of plasma distribution is calculated based on the fluorescence of the marker molecules and the fluorescence of the marker molecules relative to the fluorescence of the reporter molecules is calculated and reported as a measure of kidney function and condition.   
     
     
         45 . The apparatus of  claim 44  wherein said optical fiber is slidable within the passageway. 
     
     
         46 . The apparatus of  claim 44  wherein said optical fiber includes a bend proximate a distal end thereof 
     
     
         47 . The apparatus of  claim 44  wherein said optical fiber is configurable for in situ delivery of excitation energy and collection of emission energy within the bloodstream a patient. 
     
     
         48 . The apparatus of  claim 44  wherein said catheter is configured for introducing the analysis composition into the blood steam of a patient.